Auricular therapy for primary dysmenorrhea: A protocol for systematic review and meta-analysis of randomized controlled trials

Background: Primary dysmenorrhea (PD) is a common problem among women. It is defined as any degree of perceived cramping pain during menstruation without any evident pathology. Auricular therapy (AT), a widely used alternative medical treatment method as part of traditional Chinese acupuncture, lacks reliable evidence to support its safety and effectiveness for PD. We aimed to conduct a meta-analysis to investigate the efficacy and safety of AT in PD and to investigate possible factors impacting the particular efficacy of AT in PD by meta-regression. Methods: This protocol followed the PRISMA guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols. The following 9 sources will be searched for randomized control trials of AT for PD: the Cochrane Central Register of Controlled Trials, PubMed, Medline, Embase, Web of Science, Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure, Chinese Science and Technology Periodicals (VIP) database and WanFang Database from inception to January 1, 2023. Primary outcomes include visual rating scales and clinical efficacy rates, while secondary outcomes include endocrine hormone indicators related to PD and adverse events. Two reviewers will work independently on study selection, data extraction, and coding, including the risk of bias assessment in the included studies. While conducting a meta-analysis, Review Manager version 5.3 will be employed. Otherwise, a descriptive analysis will be performed. The results will be displayed as a risk ratio with 95% confidence intervals for dichotomous data as well as weight mean difference or standardized mean difference with 95% confidence intervals for continuous data. Results: This study’s protocol will investigate the efficacy and safety of AT in the treatment of PD in a systematic way. Conclusion: This systematic evaluation will objectively and systematically assess the efficacy and safety of AT in PD based on the available evidence, as well as provides clinicians with evidence to support the treatment of the disease.